Drugs / Levoleucovorin
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Levoleucovorin

Developed for
colorectal cancer · gastric adenocarcinoma · gastric cancer · hepatocellular carcinoma · autism spectrum disorder · esophageal squamous cell carcinoma · gastroesophageal junction adenocarcinoma · language disorder
+20 more · ampulla of vater cancer · biliary tract cancer · cholangiocarcinoma · colon carcinoma · colon mucinous adenocarcinoma · colon signet ring cell adenocarcinoma · colonic neoplasm · gallbladder cancer · malignant pancreatic neoplasm · metastatic malignant neoplasm in the colon · metastatic neoplasm · neuroendocrine carcinoma · pancreatic adenocarcinoma · pancreatic ductal adenocarcinoma · rectal cancer · rectal carcinoma · rectal neoplasm · rectal signet ring cell adenocarcinoma · rectum mucinous adenocarcinoma · peritoneal carcinomatosis
Investigated by
Fujian Cancer Hospital · Merck Sharp & Dohme LLC · National Cancer Center Hospital East · Southwest Autism Research & Resource Center · State University of New York - Downstate Medical Center · Wyeth is now a wholly owned subsidiary of Pfizer
+29 more · Amgen · Asan Medical Center · Autism Speaks · Cancer Research UK · Centre Oscar Lambret · Centro Ricerche Cliniche di Verona · China Medical University, China · Daiichi Sankyo · Hiroshima Prefectural Hospital · Hoffmann-La Roche · Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Jiangsu Hengrui Pharmaceutical Co., Ltd. · John Hays · Kyungpook National University Hospital · National Cancer Center, Korea · National Cancer Institute, Naples · National Hospital Organization Shikoku Cancer Center · Ono Pharmaceutical Co., Ltd. · Sanofi · Spanish Group for Research in Neuroendocrine Tumors · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sun Yat-sen University · The Christie NHS Foundation Trust · The First Hospital of Jilin University · Tianjin Medical University Cancer Institute and Hospital · Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan · United States Department of Defense · Wen Li · Yu jiren

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) FUSILEV — 2011-04-29 fda.gov ↗
Approved US (FDA) FUSILEV — 2008-03-07 fda.gov ↗

Trials 31

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT06538207 Jan 2021 → Oct 2024 malignant pancreatic neoplasm Ono Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT06780111 Jul 2025 → Jan 2032 expected esophageal squamous cell carcinoma Merck Sharp & Dohme LLC Recruiting No outcome recorded
Phase 1/2 NCT06428409 Jun 2024 → Oct 2029 expected biliary tract cancer, colorectal cancer, pancreatic ductal adenocarcinoma Merck Sharp & Dohme LLC Recruiting No outcome recorded
Phase 1/2 NCT05319639 Feb 2023 → Oct 2024 overdue gastric cancer Fujian Cancer Hospital Recruiting No outcome recorded
Phase 222 trials
Phase 2 NCT07621497 Jun 2026 → Jun 2029 expected metastatic malignant neoplasm in the colon Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 2 NCT07061080 Dec 2025 → Sep 2026 neuroendocrine carcinoma Spanish Group for Research in Neuroendocrine Tumors Terminated No outcome recorded
Phase 2 NCT07559760 Nov 2025 → May 2027 expected colorectal cancer The First Hospital of Jilin University Recruiting No outcome recorded
Phase 2 NCT07119931 Sep 2025 → Dec 2027 expected hepatocellular carcinoma Tianjin Medical University Cancer Institute and Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07018570 Jul 2025 → Jun 2030 expected gastroesophageal junction adenocarcinoma National Cancer Center Hospital East Recruiting No outcome recorded
Phase 2 NCT06607107 Feb 2024 → Jan 2026 overdue hepatocellular carcinoma Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Recruiting No outcome recorded
Phase 2 NCT06197438 Jan → Apr 2024 gastric cancer Fujian Cancer Hospital Unknown No outcome recorded
Phase 2 NCT05715931 May 2023 → Feb 2026 overdue gastric adenocarcinoma, gastroesophageal junction adenocarcinoma Yu jiren Active not recruiting No outcome recorded
Phase 2 NCT05797883 Aug 2022 → Dec 2023 colorectal cancer China Medical University, China Unknown No outcome recorded
Phase 2 NCT04745988 Nov 2021 → Aug 2026 overdue gastric cancer National Cancer Center Hospital East Active not recruiting No outcome recorded
Phase 34 trials · 1 met primary
Phase 3 NCT06509126 Jun 2024 → Jan 2028 expected colorectal cancer National Cancer Institute, Naples Recruiting No outcome recorded
Phase 3 NCT01926236 Feb 2014 → Jan 2018 ampulla of vater cancer, cholangiocarcinoma, gallbladder cancer The Christie NHS Foundation Trust Completed Met primary
Phase 3 NCT00195585 Oct 2002 → Feb 2006 colon carcinoma Wyeth is now a wholly owned subsidiary of Pfizer Completed No outcome recorded
Phase 3 NCT00195572 May 2002 → Aug 2008 gastric cancer Wyeth is now a wholly owned subsidiary of Pfizer Completed No outcome recorded
Phase not applicable1 trial
— NCT04174339 Dec 2019 → Dec 2020 gastric adenocarcinoma Fujian Cancer Hospital Unknown No outcome recorded
Comparator or background therapy73 trials
Phase 1 NCT05546853 Background Mar 2023 → Dec 2024 pancreatic ductal adenocarcinoma University Hospital, Grenoble Completed No outcome recorded
Phase 1 NCT05087992 Background Nov 2021 → Oct 2023 digestive system cancer Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT06540261 Background Sep 2021 → Dec 2027 expected colorectal cancer Ono Pharmaceutical Co., Ltd. Active not recruiting No outcome recorded
Phase 1 NCT06532344 Background Jul 2021 → Jun 2027 expected malignant pancreatic neoplasm Ono Pharmaceutical Co., Ltd. Active not recruiting No outcome recorded
Phase 1 NCT03798626 Background May 2019 → Mar 2023 colorectal cancer, gastroesophageal cancer, renal cell carcinoma Novartis Pharmaceuticals Completed No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2025-11-20 Ono Pharmaceutical Co., Ltd. Regulatory Ono Receives Supplemental Approval of Combination Therapy with BRAFTOVI® Capsule, a BRAF Inhibitor, for the Indication of Colorectal Cancer ono-pharma.com ↗
2018-11-21 Upsher-Smith Laboratories Regulatory MHLW Approves New Indication for LEVOFOLINATE I.V. Infusion upsher-smith.com ↗
This approval expands the indication of LEVOFOLINATE I.V. Infusion 25 mg [SAWAI] and 100 mg [SAWAI] to include the same uses as their brand equivalents.

All press releases naming this drug 2 releases

DateIssuerRelease

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 104 sources stand behind the page.

FieldValueCited text
Known as Levoleucovorin “This regimen consists of levoleucovorin 200 milligram/meter per square (mg/m\^2) or racemic leucovorin 400 mg/m\^2, oxaliplatin 85 mg/m\^2, bolus 5-fluorouracil 400 mg/m\^2,...” NCT02468557 ↗
45

“Forty-one participants will receive the treatment NALIRIFOX (liposomal irinotecan, 5-fluorouracil, levoleucovorin and oxaliplatin) until progression or unacceptable toxicity.” PMID 39987459 ↗ Feb 2025

“200 mg/m2 (Or levoleucovorin 100 mg/m2. If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted) IV over 2 hours.” NCT01652196 ↗

“5-fluorouracil \[continuous infusion\], leucovorin \[administered IV\] (or levoleucovorin \[administered IV\]), and oxaliplatin \[administered IV\]” NCT04952753 ↗

“Oxaliplatin 85 mg/m2, Levoleucovorin 200mg (or Leucovroin, Leucosodium 400mg)/m2, 5- FU 400 mg/m2, and continuous 5- FU 2,400 mg/m2 for 46 hours” NCT05673772 ↗

“in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks” NCT05609370 ↗

“The LV5FU2 regimen includes folinic acid (400 mg/m², or 200 mg/m² if levo-leucovorin is used) as a two-hour IV infusion” NCT07124884 ↗

“Leucovorin 400 mg/m² IV infusion over 120 minutes, or 200 mg/m² levo-leucovorin if leucovorin is unavailable” NCT03343301 ↗

“Levofolinic Acid For Injection is the first approved class 2.1 sodium levoleucovorin formulation in China.” NCT07621497 ↗

“oxaliplatin 85 mg/ m\^2 + leucovorin 400 mg/ m\^2 (or 200 mg/ m\^2 levo-leucovorin) as a 2-hr IV infusion” NCT00609622 ↗

“Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available.” NCT03904043 ↗

Show 35 more sources

Known as Calcium levofolinate “Treatment with LV5FU2 (5-FU, Calcium Levofolinate) - paclitaxel, regular tumor evaluation, best supportive care Other authorized treatment : usual paclitaxel pre-treatment...” NCT03301454 ↗
18

“The treatment option for the standard second-line FOLFIRI + bevacizumab therapy group is bevacizumab 5 mg/kg IV Drip Q2W, irinotecan 180 mg/m2 IV Drip Q2W, calcium folinate 400...” NCT05768503 ↗

“mFOLFOX7(Oxaliplatin 85mg/m2, Calcium Levofolinate 200mg/m2, Fluorouracil 400 mg/m2 D1,2400mg/m2 maintain 46 hours,) combined with Apatinib and Camrelizumab 200mg every 3 weeks.” NCT06607107 ↗

“The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).” NCT03244774 ↗

“The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).” NCT02697838 ↗

“The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).” NCT04121039 ↗

“folinic acid 400 mg/m2 or calcium levofolinate 200 mg/m2 given as a 2-h IV infusion” NCT06757244 ↗

“followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).” NCT03788174 ↗

“Calcium folinatc 400 mg/m2 or Calcium Levofolinate 200 mg/m2 D1” NCT03686254 ↗

“calcium levofolinate, 200 mg/m2 infusion for 1 hours” NCT05582278 ↗

“and Calcium Levofolinate (200 mg/m2)” NCT03707639 ↗

Show 8 more sources

Known as Isovorin ClinicalTrials.gov intervention name — accepted as the source's own label NCT00316745 ↗
3

NCT00195585 ↗

NCT00195572 ↗

NCT01524094 ↗

Known as L-folinic acid “oxaliplatin 85 mg/m² and l-folinic acid 200 mg/m² or d,l-folinic acid 400 mg/m² concurrently, as a 2-hour IV infusion” NCT05712356 ↗
7

“Folinic acid: 400 mg/m² intravenous over 30 minutes or L-folinic acid (racemic form L) 200 mg/m² over 30 minutes” NCT03719924 ↗

“FOLFIRI: 200 mg L-folinic acid given concurrently with 180 mg/ m² irinotecan over 1.30 h IV infusion” NCT05312398 ↗

“L-Folinic acid 100 mg/m2 IV infusion of 2 hours” NCT01878422 ↗

“L-folinic acid 200 mg/m2 IV” NCT06790706 ↗

NCT06509126 ↗

NCT01926236 ↗

NCT03294252 ↗

Known as l-LV “oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab” NCT02394795 ↗
2

“oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab” NCT02337946 ↗

“Levofolinate calcium (l-LV)” NCT02497157 ↗

Known as Leucosodium “Levoleucovorin 200mg (or Leucovroin, Leucosodium 400mg)/m2” NCT05673772 ↗
Known as Leucovroin “Levoleucovorin 200mg (or Leucovroin, Leucosodium 400mg)/m2” NCT05673772 ↗
Known as Levofolinate “Patients were randomly assigned (1:1; block size of three), without stratification, to receive FOLFIRI (irinotecan 180 mg/m2, calcium folinate 400 mg/m2 or levofolinate 200...” PMID 36739879 ↗ Feb 2023
11

“400 mg/m2 folinic acid or 200 mg/m² levofolinate in a 2-h infusion” NCT07061080 ↗

“Nanoliposomal irinotecan, Fluorouracil, Levofolinate” NCT05601323 ↗

“Levofolinate 100 mg/m2 iv: day 1-2” NCT02000050 ↗

NCT06532344 ↗

NCT06538207 ↗

NCT04745988 ↗

NCT07018570 ↗

NCT06540261 ↗

NCT01882868 ↗

NCT02641873 ↗

Show 1 more source

Known as levofolinate calcium ClinicalTrials.gov intervention name — accepted as the source's own label NCT02394795 ↗
2

NCT02497157 ↗

NCT02337946 ↗

Known as Levofolinic Acid “Levo-folinic acid (LFA) will be allowed as a substitute for FA in the mFOLFOX-6 chemotherapy regimen” NCT01111604 ↗
9

“followed by levo-folinic acid 200 mg/m2 as 1- 2 hours i.v. infusion followed by i.v bolus.” NCT04310176 ↗

“Levofolinic Acid 200mg/m² continuous mixed infusion” NCT05797883 ↗

NCT07559760 ↗

NCT01718873 ↗

NCT06041477 ↗

NCT01383707 ↗

NCT01590719 ↗

NCT01481545 ↗

NCT03528785 ↗

Known as Levofolinic Acid For Injection “Levofolinic Acid For Injection is the first approved class 2.1 sodium levoleucovorin formulation in China.” NCT07621497 ↗
Known as Levoleucovorin Calcium ClinicalTrials.gov intervention name — accepted as the source's own label NCT04060030 ↗
1

NCT04060017 ↗

Known as LFA “Levo-folinic acid (LFA) will be allowed as a substitute for FA in the mFOLFOX-6 chemotherapy regimen” NCT01111604 ↗
Known as Zuoyu “Levofolinic Acid (Zuoyu ®)” NCT05797883 ↗
Route Intravenous “200 mg/ m\^2 levo-leucovorin) as a 2-hr IV infusion” NCT00609622 ↗